Dedicated Support for DPIs, MDIs, Nebulizers, and Nasal Sprays

Our scientists utilize the latest instrumentation and methodologies to provide customers with the highest quality of analytical analysis of MDI’s, DPI’s, nebulizers, and nasal drug products. We develop a specific program to meet all requirements necessary including stability storage conditions and determining the relevant experiments needed according to the industry guidance. At the completion of each project, we provide customers with detailed reports ready for regulatory submission.

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Development Services


  • Next Generation Impactor
  • Andersen Cascade Impaction
  • Unit Dose Sampling Apparatus
  • Copley Critical Flow Controller
  • SprayView (spray characterization)
  • Automated actuation systems
  • Polarized light microscope
  • Spray force tester
  • Breath simulator
  • Karl Fischer
  • FTIR
  • Waters HPLC systems
  • GC-MS
  • GC-HS
  • LC-MS

Methods (Available with any Service)

  • Assay

  • Impurities and Degradation

  • Related Substances

  • Preservative Assay

  • Particle Size

  • Droplet Size by Laser Diffraction

  • Aerodynamic Particle Size

  • Dose Content Uniformity

  • Spray Pattern

  • Plume Geometry

  • Pump Delivery

  • Shot Weight

  • Surface Tension

  • Viscosity

  • Moisture Content

  • Osmolality

  • Microbial limits

  • Particulate Matter

  • Identification

  • Appearance

  • Color

  • Weight loss

  • Net Content

  • Nasal Cast Deposition

  • Spray force


  • Registered with FDA (last inspection January 2016 – no 483s)
  • DEA license for controlled drug substances (schedule II-V)
  • cGMP compliant laboratory, ISO 17025 Accredited and EQFAR certified laboratory through ANVISA
  • Accredited to ISO/IEC 17025:2005
  • Subject matter experts in:
    • Analytical chemistry
    • Inhalation physical tests
    • Spray characterization
    • Particle size analysis

Regulatory Experience

We have a proven track record of working with regulatory agencies to ensure a higher product approval rate.

  • US (FDA)
  • EU (European Medicines Agency) & Australia
  • Canada (Health Canada)
  • Americas
  • India
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